<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20181111041611N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-25</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of nutrition education on improving growth indicators and food intake in 7-12 year old children suffering from malnutrition</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of nutritional education based on the precede-Proceed model and according to the food basket introduced by the Ministry of Health on improving the growth indicators and food intake of malnourished children aged 7-12 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>254</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71308</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: The current study is a randomized controlled trial (clinical trial) that will be conducted on 254 children aged 7 to 12 with malnutrition who are randomly divided into two groups of 127 intervention and control. The intervention group receives nutrition education and the control group does not receive any education, Randomization description: The participants of this study from public and non-profit primary schools in Kermanshah city were identified by student using anthropometric indicators and growth monitoring charts, and taking into account the entry and exit criteria, they were registered and enrolled. Then, using block randomization method, they are divided into intervention and control groups. The size of the blocks is not equal and is chosen randomly, which can include 10 blocks of 20, 5 blocks of 10 and 2 blocks of 2, and there are equal numbers of each group A and B in each block. A): intervention group and B: control group)
Random numbers are generated by the statistical consultant and the random allocation of people to two groups of intervention and control will be done by the project manager (supervisor) and the student is not aware of this allocation. Coded boxes will also be used to hide random sequences.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Malnutrition.</hc_freetext>
      <i_freetext>Intervention group: 127 children aged 7 to 12 suffering from malnutrition in the city of Kermanshah who have been subjected to the intervention of an educational program that, according to the information of the initial questionnaire, educational needs assessment, prioritization of these educations and determination of educational goals are carried out and these educations can include group education food, healthy eating, food variety, meat substitutes, protein sources, food containing vitamins, minerals such as iron, calcium and zinc, the amount of daily body needs from food groups and how to prepare food according to the child's interest, which It will be prepared from each training session. The trainings are weekly for 2 months and each session lasts 45 to 60 minutes in the form of face-to-face lectures, group discussions, worksheets, questions and answers, and educational videos, which will be conducted in the presence of students, their parents, and teachers..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehnoosh Samadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutritional Sciences, Faculty of Nutritional Sciences and Food Industry, Dowlatabad Blvd, Itsar Square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851552</zip>
        <telephone>+98 83 3710 2009</telephone>
        <email>mehnoosh_samadi@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehnoosh Samadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nutritional Sciences, Faculty of Nutritional Sciences and Food Industry, Dowlatabad Blvd, Itsar Square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851552</zip>
        <telephone>+98 83 3710 2009</telephone>
        <email>mehnoosh_samadi@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to cooperate
Suffering from mild, moderate and severe levels of malnutrition
Children's age ranges from 7 to 12 years
Not using vitamin and mineral supplements
Not having underlying, genetic diseases
Absence of acute digestive and respiratory infections, acute-chronic renal failure, attention deficit</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue cooperation
Hospitalization
Accidents</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified protein-calorie malnutrition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 127 children aged 7 to 12 suffering from malnutrition in the city of Kermanshah who have been subjected to the intervention of an educational program that, according to the information of the initial questionnaire, educational needs assessment, prioritization of these educations and determination of educational goals are carried out and these educations can include group education food, healthy eating, food variety, meat substitutes, protein sources, food containing vitamins, minerals such as iron, calcium and zinc, the amount of daily body needs from food groups and how to prepare food according to the child's interest, which It will be prepared from each training session. The trainings are weekly for 2 months and each session lasts 45 to 60 minutes in the form of face-to-face lectures, group discussions, worksheets, questions and answers, and educational videos, which will be conducted in the presence of students, their parents, and teachers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Scores of predisposing factors including (score of awareness, attitude and self-efficacy), strengthening and enabling factors. Timepoint: Before the intervention, 1 month and 3 months after the intervention. Method of measurement: PRECEDE questionnaire.</prim_outcome>
      <prim_outcome>Height-for-age. Timepoint: before the intervention, 1 month and 3 months after the intervention. Method of measurement: WHO height-for-age chart.</prim_outcome>
      <prim_outcome>Weight-for-age. Timepoint: before the intervention, 1 month and 3 months after the intervention. Method of measurement: WHO weight-for-age chart.</prim_outcome>
      <prim_outcome>BMI for age. Timepoint: Before the intervention, 1 month and 3 months after the intervention. Method of measurement: BMI chart for age WHO.</prim_outcome>
      <prim_outcome>Food intake. Timepoint: Before the intervention, 1 month and 3 months after the intervention. Method of measurement: Food record questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-09</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
